Director Toxicology CA
Company: Jazz Pharmaceuticals
Location: Palo Alto
Posted on: May 7, 2024
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Job Description:
If you are a Jazz employee please apply via the Internal Career
site
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global
biopharmaceutical company whose purpose is to innovate to transform
the lives of patients and their families. We are dedicated to
developing life-changing medicines for people with serious diseases
- often with limited or no therapeutic options. We have a diverse
portfolio of marketed medicines and novel product candidates, from
early- to late-stage development, in neuroscience and oncology. We
actively explore new options for patients including novel
compounds, small molecules and biologics, and through cannabinoid
science and innovative delivery technologies. Jazz is headquartered
in Dublin, Ireland and has employees around the globe, serving
patients in nearly 75 countries. For more information, please visit
www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.
Brief Description:
The Director, Toxicology is accountable for managing the global
nonclinical regulatory and investigative toxicology of assigned
Jazz portfolio products, and likewise to support his/her reports
overseeing those products. They will collaborate with their direct
reports and other members of the toxicology group, Early
Development non-clinical scientists, and members of Jazz
cross-functional matrix teams to support the overall global
nonclinical regulatory strategy of Jazz programs, from research to
registration and beyond. The Director, Toxicology, reports to the
Head of Toxicology.
Essential Functions
The eligible candidate is experienced in leading, supporting and
managing direct reports. The Director, Toxicology has the necessary
qualifications and experience for designing and
conducting/monitoring toxicology studies at external CROs,
interpreting and reporting toxicology findings, and enabling timely
high-quality study deliverables. They will have the necessary
experience for representing Toxicology in cross-functional teams
supporting drug development programs and conveying Toxicology
consensus position, identifying and pre-emptying potential
toxicology issues that may slow or derail a program, and propose
adequate de-risking strategies to address or circumvent such
issues. Experience is also required in evaluating and preparing
responses to inquiries from health authorities addressing global
nonclinical development issues in support of IND/CTA and
NDA/NDS/BLA packages. The individual has the necessary knowledge
and experience to contribute to or lead early development
cross-functional teams.
The Director, Toxicology:
Is a motivated self-starter with excellent management capabilities
and is a critical part of an innovative team that supports the
company's drug discovery/development effort.
Conceptualizes, develops, revises, and finalizes toxicology (GLP
and non-GLP) study designs and reports; drafts nonclinical sections
for IND/CTA and NDA/BLA submissions and other regulatory documents
(e.g., IB, DSUR, PSUR, etc.) to ensure regulatory compliance.
Manages and monitors nonclinical studies (GLP and non-GLP) at
external CROs per Jazz standards and ensures that global
regulatory/compliance requirements are met/exceeded.
Critically reviews and edits CRO nonclinical toxicology study
reports, analyzes and interprets data, defines PK/PD and
PK/Toxicity correlations, partners in PK modeling and parameter
estimation, and coordinates reports' finalization with CROs upon
internal review and team communication, ensuring consistency with
global regulatory and compliance requirements.
Provides critical input on discovery and nonclinical development
strategy including peer review of pharmacology/pharmacokinetic
protocols, reports, and regulatory content.
Leads and/or participates in cross functional teams as early
development expert to ensure proper integration of these activities
into overall project plans.
Partners with and provides subject matter expertise to key internal
functions (regulatory, Quality, Clinical, CMC and formulations,
Product Quality, Drug safety, Medical affairs) and their external
contractors or collaborators.
Contributes to departmental processes such as SOP's, WI's and
templates.
Maintains a current understanding of relevant literature and
methodology, as well as the scientific literature related to the
assigned Jazz pipeline products and R&D projects.
Required Education, Licenses, Knowledge, Skills, and Abilities
As a minimum, Ph.D. in Toxicology, Pharmacology, Pathology,
Biochemistry or Biology with extensive pharmaceutical industry
experience in drug development toxicology. Board certification
(e.g., DABT, ERT) is highly desirable, or demonstrable board
eligibility with the intention to write the board exam.
A minimum of 8-10 years of experience with small and large
molecules with a preference for oncology and CNS indications.
Experience in outsourcing and monitoring toxicology studies, CRO
management, and interacting with study directors and other vendors
(e.g., consultants) to obtain timely delivery of clear, accurate,
and well-written toxicology study reports with defensible data
analyses and data interpretation. Capacity to synthesize and
communicate complex information. Capacity to propose practical
mitigation (de-risking) strategies.
Strong knowledge of FDA, EMA, and ICH guidance documents and GLP
regulations.
Required experience in authoring non-clinical elements of major
regulatory submissions (INDs, CTAs, BLA/NDAs or sNDAs) and other
regulatory documents (e.g., IB, PSUR, DSUR); preparing
science-based responses to regulatory questions.
Deep understanding of QA, regulatory, and clinical functions to
guide key nonclinical safety assessment activities to support drug
candidates' success at all stages of development.
Ability to synthesize, interpret and integrate diverse,
multidisciplinary scientific data (e.g., pharmacology,
pharmacokinetics, pathology).
Experience in Discovery Toxicology as applicable to early stages
(non IND-enabling) drug development would be a plus.
Excellent verbal communication and scientific writing skills as
applied to study reports and regulatory documents. Ability to
interact effectively and tactfully with a variety of critical
audiences within and outside the organization. Sense of
urgency.
Enjoys and thrives in a fast-paced, multi-tasked, and hands-on
environment.
Jazz Pharmaceuticals is an equal opportunity/affirmative action
employer and all qualified applicants will receive consideration
for employment without regard to race, color, religion, sex,
national origin, disability status, protected veteran status, or
any characteristic protected by law.
FOR US-BASED CANDIDATES ONLY
Jazz Pharmaceuticals, Inc. is committed to fair and equitable
compensation practices and we strive to provide employees with
total compensation packages that are market competitive.
For this role, the full and complete base pay range is
$192,000-$288,000. Individual compensation paid within this range
will depend on many factors, including qualifications, skills,
relevant experience, job knowledge, and other pertinent factors.
The goal is to ensure fair and competitive compensation aligned
with the candidate's expertise and contributions, within the
established pay framework and our Total Compensation philosophy.
Internal equity considerations will also influence individual base
pay decisions. This range will be reviewed on a regular basis.
At Jazz, your base pay is only one part of your total compensation
package. The successful candidate may also be eligible for a
discretionary annual cash bonus or incentive compensation
(depending on the role), in accordance with the terms of the
Company's Global Cash Bonus Plan or Incentive Compensation Plan, as
well as discretionary equity grants in accordance with Jazz's Long
Term Equity Incentive Plan.
The successful candidate will also be eligible to participate in
various benefits offerings, including, but not limited to, medical,
dental and vision insurance, 401k retirement savings plan, and
flexible paid vacation. For more information on our Benefits
offerings please click here:
https://careers.jazzpharma.com/benefits
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Keywords: Jazz Pharmaceuticals, Salinas , Director Toxicology CA, Executive , Palo Alto, California
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